Animal Care Program Research Articles

0031 Applying AAALAC international's peer review program to support agricultural research programs

Agricultural animal research is arguably more important today than ever before. The challenge of providing food for the world's population in a sustainable, ethical manner is no small task. Public awareness regarding animal production is increasingly focused on humane treatment and methods, while at the same time there is a significant lack of understanding about production animals, their needs, and the best practices to rear and care for them. Institutions that engage in animal research and production must ensure that high standards of animal care and use are used both to meet expectations of society and to be ethical stewards of the animals with which we work. AAALAC International provides a third party, peer review of all facets of the animal care and use program that has proven to be an effective mechanism to ensure institutions meet the standards of the Ag Guide, undergo continuous improvement, and demonstrate institutional commitment to high standards of animal care and use. Data from 671 AAALAC site visits highlight the common challenges faced by animal care and use programs and provide information to aid those engaged in research animal program management. Findings data in each of the six main areas of the animal program will be provided: institutional commitment and resources, personnel expertise and training, husbandry and veterinary care, occupational health and safety, facilities, and effective oversight by the institutional animal care and use committee. An AAALAC review by peers who are experienced in agricultural animal research is collegial, confidential, and outcome-based. It is designed to help identify strengths and weaknesses of the program, with the aim of ensuring high quality scientific outcomes and a high level of animal welfare.

Lapse in Institutional Animal Care and Use Committee Continuing Reviews.

The United States federal animal welfare regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals require that institutional animal care and use committees (IACUCs) conduct continuing reviews of all animal research activities. However, little is known about the lapse rate of IACUC continuing reviews, and how frequently investigators continue research activities during the lapse. It is also not clear what factors may contribute to an institution’s lapse in IACUC continuing reviews. As part of the quality assurance program, the Department of Veterans Affairs (VA) has collected performance metric data for animal care and use programs since 2011. We analyzed IACUC continuing review performance data at 74–75 VA research facilities from 2011 through 2015. The IACUC continuing review lapse rates improved from 5.6% in 2011 to 2.7% in 2015. The rate of investigators continuing research activities during the lapse also decreased from 47.2% in 2012 to 7.4% in 2015. The type of IACUCs used and the size of animal research programs appeared to have no effect in facility’s rates of lapse in IACUC continuing reviews. While approximately 80% of facilities reported no lapse in IACUC continuing reviews, approximately 14% of facilities had lapse rates of >10% each year. Some facilities appeared to be repeat offenders. Four facilities had IACUC lapse rates of >10% in at least 3 out of 5 years, suggesting a system problem in these facilities requiring remedial actions to improve their IACUC continuing review processes.

A retrospective review of postapproval monitoring at a large academic institution

Institutional Animal Care and Use Committees (IACUCs) are federally mandated to ensure the welfare of animals used in research, testing and teaching. An IACUC must oversee institutional animal care and use programs and promote compliance with all regulations and policies. Postapproval monitoring (PAM) is one administrative tool that an IACUC can implement to help fulfill its federal and societal responsibility. Here, the authors describe the PAM program at a large academic institution, considering the program's accomplishments and how the program has changed since its inception. The authors also provide a retrospective analysis of compliance records during the first 10 y of the program, which demonstrate improved compliance following initiation of PAM.

IACUC Considerations for the Use of Livestock in Translational Research.

Through its program oversight function, the institutional animal care and use committee (IACUC) plays a central role in ensuring the humane use and care of animals in research. To be effective in this role, the IACUC requires explicit knowledge of the species for which it bears oversight responsibility. Owing to a variety of species-specific factors, such as their relatively large size and range of acceptable housing environments, livestock present many special considerations for the IACUC. This article reviews many of those considerations in a format intended to aid IACUCs in the review of animal care and use programs involving livestock species used in translational research.

Current regulations and requirements for managing an animal care and use program.

Current regulations and requirements for managing an animal care and use program.

Animal care and use programs for multiple campuses.

Animal care and use programs for multiple campuses.

Survey of Beef Quality Assurance on California dairies

In October 2011, a mail and online survey of California dairy personnel was conducted to assess producer familiarity with and support of the Dairy Animal Care and Quality Assurance (DACQA) program. The DACQA program addresses cattle of all ages (birth to culling) and standard practices that affect the use of dairy cattle for beef. The survey was mailed to a random sample of 1,071 California dairies (65%) stratified by county, proportional to the number of dairies in each respective county. Data from the 158 responses received (15%) showed that 90% of culled cows on California dairies were sold for beef. However, personnel on more than one-half of California dairies (56%) had no knowledge of how their herd cull cows ranked in terms of beef quality measures (body condition score, US Department of Agriculture carcass grade, and hot carcass weight). Survey results showed that a considerable proportion of California dairy personnel were aware of recommended injection practices including a preference for subcutaneous injections (45%). A drug inventory was maintained on approximately 50% of the state's dairies. Management at these dairies was twice as likely to test for drug residues compared with dairies that did not maintain a drug inventory. More information about the DACQA program was requested by more than half of California dairies.

What Investigators Need to Know About the Use of Animals

Investigators conducting research with animal subjects have an ethical and legal responsibility to ensure they are treated humanely. The system of animal research oversight in the United States consists of a framework of federal, state, local, and institutional requirements. Institutions supported by the Public Health Service (PHS) are required to follow the guidelines mandated by the PHS Policy on Humane Care and Use of Laboratory Animals and establish institutional animal care and use committees (IACUC) to oversee animal research activities. This system of self-monitoring at the local level is central to assuring an effective and compliant animal care and use program. Integral to this system is the responsibility of the investigator for the stewardship of their research animal subjects. No activities may be conducted without IACUC approval. Investigators are accountable for all aspects of their animal research activities from preparing their funding applications and complying with the terms and conditions of awards to protecting the investment in research with animals. This review acts as a succinct resource and provides references for investigators supported by the PHS to understand the main expectations and requirements when using animals in research.

An insurance policy (and more) for the animal care and use program

An insurance policy (and more) for the animal care and use program

Using principles from emergency management to improve emergency response plans for research animals

Animal research regulatory agencies have issued updated requirements for emergency response planning by regulated research institutions. A thorough emergency response plan is an essential component of an institution's animal care and use program, but developing an effective plan can be a daunting task. The author provides basic information drawn from the field of emergency management about best practices for developing emergency response plans. Planners should use the basic principles of emergency management to develop a common-sense approach to managing emergencies in their facilities.

Regulatory requirements for providing adequate veterinary care to research animals

Provision of adequate veterinary care is a required component of animal care and use programs in the United States. Program participants other than veterinarians, including non-medically trained research personnel and technicians, also provide veterinary care to animals, and administrators are responsible for assuring compliance with federal mandates regarding adequate veterinary care. All program participants therefore should understand the regulatory requirements for providing such care. The author provides a training primer on the US regulatory requirements for the provision of veterinary care to research animals. Understanding the legal basis and conditions of a program of veterinary care will help program participants to meet the requirements advanced in the laws and policies.

Applying the principles of disaster prevention to decrease adverse events in a research program

In an animal care and use program in a research setting, events that have a negative impact on animal well-being do not typically occur spontaneously and arbitrarily. It takes the convergence of multiple missteps, miscalculations and misinterpretations of conditions for a serious accident to take place. Two concepts drawn from wilderness survival training can be applied to any research animal care and use program to reduce adverse events. The first, derived from the accident matrix model, is the concept of 'problem vectors,' or conditions, behaviors and policies that increase the likelihood of an adverse event. Identifying problem vectors and diverting them before they intersect to create an adverse event can considerably improve animal well-being and reduce the number of protocol violations and reportable events. The second concept is that of doing the 'next right thing' when an adverse event does occur in an animal program. The next right thing is a response characterized by unified directed action toward fixing problems without engaging in behaviors that might worsen the situation. Adopting an institution-wide approach of diverting problem vectors and pursuing the next right thing can result in better prevention and management of adverse events.

A training primer for Institutional Officials

The laws and policies governing the care and use of animals in research in the US require institutions to establish training programs to assure that personnel are qualified for their roles in animal care and use programs. Few programs define specific training requirements for the Institutional Official (IO), one of the most important roles in an animal care program. In some cases, IOs may have little or no experience in biomedical science. In this article, the author provides an overview of the IO's role in an animal care and use program as defined by US government laws and policies for use in training IOs and chief executive officers. The author outlines the key responsibilities of the IO in an animal care program, the implications of noncompliance with federal requirements and some of the pitfalls in program design.

Implementing positive reinforcement animal training programs at primate laboratories

In the last decade several surveys of primate care and training programs highlight a common theme; despite scientific evidence that animal training can be effective in reducing stress, increasing efficiency and improving veterinary care, animal training is not widely incorporated into animal care and management programs in laboratory settings. This is particularly important with the recent release of the internationally recognized version of the “Guide for the Care and Use of Laboratory Animals” by the National Research Council. The Guide includes multiple recommendations to incorporate training methods into husbandry and experimental procedures. To address the divide between the regulatory and scientifically based support for animal training, and a broader establishment of formal animal training programs, this paper will: describe three approaches to structuring animal training programs; provide rationale as to why facilities should have animal training programs; report on a recent survey of animal training programs at nine, large USA facilities housing nonhuman primates; discuss important elements of an animal training program; discuss negative reinforcement and means to minimize its use; and finally give a detailed description of a facility-wide animal training program.

Managing an animal care program

An interview with Larry Young, RVT, LATg, CPIA, Animal Care Program Manager, San Jose State University, San Jose, CA

Management strategies for controlling endemic and seasonal mouse parvovirus infection in a barrier facility

Despite improved diagnostic and rederivation capabilities, research facilities still struggle to manage parvovirus infections (e.g., mouse parvovirus (MPV) and minute virus of mice) in mouse colonies. Multi-faceted approaches are needed to prevent adventitious organisms such as MPV from breaching a barrier facility. In this article, the authors document recent changes to the Salk Institute's animal care program that were intended to help manage mouse parvovirus in the barrier facility. Specifically, the Institute started to use a new disinfectant and to give mice irradiated feed. The authors found an association between these modifications and a reduction in MPV incidence and prevalence in endemically infected colonies. These data suggest that using irradiated feed and appropriate disinfectants with contemporary management practices can be an effective plan for eradicating or controlling MPV infection in a research facility. The authors recommend further study of the environmental risk factors for parvovirus infection and of potential biological interactions associated with the use of irradiated feed.

Animal Housing Facilities: Session Introduction

I t’s a pleasure to moderate this session on animal housing facilities. When I first got involved in the care of labora­ tory animals (I think it was 1950), our facility was called the Animal House. It was located next to the Residents’ Housing on the VA Station where I lived until I was 8 years old; I was taking care of guinea pigs on weekends for about 50 cents. Twenty-eight years later, I became the director of the Biological Resources Laboratory (BRL) at the Univer­ sity of Illinois at Chicago (UIC). I hope none of you postdocs out there take that long to achieve success. The BRL, often called the animal hospital by many of the users, was in fact a state-of-the-art facility for the time, having been the initial facility where the Illinois Cubicles were devel­ oped and used. By the time I retired from the UIC, the BRL had undergone many major and minor renovations to be­ come what it is—and what most other animal housing fa­ cilities are today—an extension of the investigator’s laboratory. In putting this session together, my goal was to call at­ tention to the progress that has been made in managing the environment in which laboratory animals are maintained. There are many reasons for this improvement but, based on my experience, the primary driver has been to minimize the impact of the housing environment on the data generated us­ ing animal-based models. The principal goal of an institu­ tional animal care and use program should be to optimize the well-being of animals that are cared for and used in that pro­ gram. Optimizing animal welfare will ensure compliance with the regulations and standards of the USDA, the PHS Policy, and the accreditation requirements of AAALAC In­ ternational. Optimizing animal welfare will also minimize nonexperimental variability and thus facilitate the research that must use animals. Today’s speakers have been chosen to highlight how far we have come in terms of the physical environment in which we house animals; to discuss how we got there by improving the facilities in which the animals are maintained and the equipment that is used to support that maintenance; and finally to look at trends in facility design and construction. I will keep the introductions brief so our speakers can con­ centrate on what you came to hear. Dr. Betty Goldentyer is the Eastern Regional Director for the APHIS Animal Care program at USDA. Betty has been with the Animal Care program since its organization as a standalone program in 1988. She will present the USDA’s perspective on how far we’ve come in terms of facility issues. Dr. Chris Newcomer is the Executive Director of AAALAC International and has participated in its review ac­ tivities for the past 25-plus years. He will present AAALAC’s perspective on how far we have come. Dr. Lauretta Gerrity is the Associate Vice President for Research Operations and Compliance and a professor in the Department of Genetics at the University of Alabama in Birmingham (UAB). She was previously Director of the Ani­ mal Research Program there. I was lucky enough to have some exposure to that program and that’s why I asked Lauretta to speak. She is going to talk about the commitment that institutions must make when they seek to obtain funding for facility improvements. Dr. Willie McCullough has been a Health Science Ad­ ministrator at NCRR since 2001. He served as Director of the Animal Facilities Improvement Program and the Re­ search Facilities Improvement Program from January 2001 to March 2010. He will talk about NCRR’s tremendous commitment to the process of improving animal housing facilities. And Dr. Steve Leary is the Assistant Vice Chancellor for Veterinary Affairs and Director of the Division of Compara­ tive Medicine at Washington University School of Medicine in St. Louis. He has over 30 years of experience in laboratory animal medicine and management of laboratory animal fa­ cilities. He has coauthored chapters on animal facility design and the use of interstitial mechanical space in animal facility design in the most recent edition of Laboratory Animal Med­ icine in the ACLAM (American College of Laboratory Ani­ mal Medicine) book series. He will address trends in facility design.

Global Impact of Animal Research on Infectious Diseases: A CDC Perspective

Policy on the Humane Care and Use of Laboratory Animals and it supports educational programs and monitors compli­ ance. This is a very important part of what we do involving our assured institutions and the PHS funding components. It ensures the humane use of animals in our research, in our testing and training, and contributes to the quality of what we do in our research. NIH also supports animal model systems and alterna­ tives. I want to say a bit more about our intramural animal care and use program and extramural support of animal re­ search. Virtually all of our institutes that have an intramural component—24 of them—have animals in their research programs. Almost 50% of the NIH-funded grants and con­ tracts that we support involve animals. As this is a major part of the research program here at NIH it is very important that we have appropriate compliance and oversight of this pro­ cess. For the intramural program in 2009, we used 1.3 mil­ lion animals; 81% of them were mice but there were more than 20 different species—fish and frogs, rats, guinea pigs, rabbits, hamsters, nonhuman primates, birds, dogs, cats, pigs, and sheep. There’s a variety of animals supported here in the intramural program, and NIH has a number of resources available if you are looking for model organisms for bio­ medical research. Our website provides information on model organisms, both mammalian and nonmammalian models in­ cluding Arabidopsis, the mustard plant. We also have a number of programs that support the de­ velopment of nonmammalian models and the improvement of mammalian models. At the National Center for Research Resources (NCRR) the Biological Models and Materials Re­ search Program supports research to develop and broaden the utility of models including cell culture, nonmammalian model organisms, and nonbiological systems such as math­ ematical modeling or computer modeling. These are exam­ ples of our interest in alternatives to the use of animals. The NCRR Laboratory Animal Science Program supports animal research–related resources and research training through awards and grants contracts and cooperative agree­ ments. Through its Division of Comparative Medicine, NCRR awards animal research grants and resource grants to develop, characterize, and improve mammalian animal models for hu­ man disease and study. NIH is interested in both improving mammalian model systems and offering nonmammalian and nonanimal alternatives. The NLM has another resource, the Bibliography on Alternatives to Animal Testing (ALTBIB), which [includes] a search engine to identify resources on al­ ternatives to the use of live vertebrates in biomedical research and testing. On the ALTBIB web page you can identify the sources, put in keywords, and find available alternatives. Much of the program for today focuses on biomedical re­ search using animal models and how it has advanced knowledge to find prevention, cures, and treatments for the many serious diseases and conditions of humans and, of course, of animals.

The Future: Continuing IACUC Challenges

in order to be granted full accreditation; the Council on Accreditation offers Suggestions for Improvement to enhance an acceptable or even commendable animal care and use pro­ gram and as a means of promoting continuous improvement in a high-quality program. The strong commitment that IACUCs at accredited institutions have made to provide ap­ propriate oversight of animal care and use programs is evi­ denced by the fact that approximately 98% of institutions have Full Accreditation [from AAALAC International]. Since the publication of the 1985 Guide, AAALAC In­ ternational has observed many examples of improvement in animal welfare and in the resulting quality of science as the IACUC has engaged in increasingly comprehensive over­ sight of the animal care and use program. Given the overarching scope of IACUC input to the animal program, the number and types of program enhancements are also broad. Examples of this improvement include

Peer to Peer Interaction Promotes Implementation of the Three Rs and Harmonization of Animal Care and Use Programs

Peer to Peer Interaction Promotes Implementation of the Three Rs and Harmonization of Animal Care and Use Programs